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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020364

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LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 2.5MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 2.5MG BASE;10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020364
Product Number: 002
Approval Date: Mar 3, 1995
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 5MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE;10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020364
Product Number: 003
Approval Date: Mar 3, 1995
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 5MG BASE;20MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020364
Product Number: 004
Approval Date: Mar 3, 1995
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 5MG BASE;40MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE;40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020364
Product Number: 007
Approval Date: Apr 11, 2006
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 10MG BASE;20MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE;20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020364
Product Number: 005
Approval Date: Jun 20, 2002
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LOTREL (AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE)
EQ 10MG BASE;40MG
Marketing Status: Prescription
Active Ingredient: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Proprietary Name: LOTREL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE;40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020364
Product Number: 006
Approval Date: Apr 11, 2006
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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